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FDA 510(k)

Portable Slit Lamp

K-Number: K153545 · 2016-06-22

ApplicantShanghai Bolan Optical-Electric Co., Ltd.
Decision Date2016-06-22
Product CodeHJO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Portable Slit Lamp is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Bolan Optical-Electric Co., Ltd.. It received FDA 510(k) clearance on 2016-06-22 under 510(k) number K153545. The device is classified under product code HJO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Portable Slit Lamp?

Portable Slit Lamp is a medical device that received FDA 510(k) clearance on 2016-06-22. The listed applicant is Shanghai Bolan Optical-Electric Co., Ltd.. The 510(k) number is K153545.

When did Portable Slit Lamp receive FDA 510(k) clearance?

Portable Slit Lamp received FDA 510(k) clearance on 2016-06-22, under 510(k) number K153545.

Who is the listed applicant for Portable Slit Lamp?

The FDA 510(k) record lists Shanghai Bolan Optical-Electric Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Portable Slit Lamp?

The FDA product code for Portable Slit Lamp is HJO.

Related Devices (Code: HJO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253834VISUREF 600Carl Zeiss Vision GmbHK231760HP-OCT (HP-OCT)Cylite Pty. , Ltd.K222372Kowa SL-19Kowa Company , Ltd.K193188MiiS Horus Eye Anterior CameraMedimaging Integrated Solution, Inc (Miis)K182306Sunkingdom Slit LampChongqing Sunkingdom Medical Instrument Co., Ltd.K173771IOLMaster 700Carl Zeiss Meditec, AG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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